Lancet device with depth adjustment and lancet removal system and method

ABSTRACT

Lancet device includes a housing, a removable front cap mounted to the housing, a lancet holding member, and a trigger. A system is utilized for placing the lancet device in a trigger-set or armed position. A depth adjustment system includes a member that is at least partially rotatably mounted and that has an axis of rotation arranged substantially perpendicular to a center axis of the lancet holding member. An ejection system is utilized for at least one of preventing axial movement of the lancet holding member and removing or ejecting a lancet from the lancet holding member.

CROSS-REFERENCE TO RELATED APPLICATIONS

The instant application is an International Application based on U.S.provisional application No. 60/929,252, filed Jun. 19, 2007, thedisclosure of which is hereby expressly incorporated by reference heretoin its entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to a lancet device which utilizes depth adjustmentand a lancet removal system. Lancet devices are used to penetrate andpuncture the skin in order to allow the taking of a blood sample fortesting. The present device allows the user to more safely remove andreplace a lancet after each use.

2. Discussion of Background Information

Lancet devices are commonly used to prick the skin of the user so thatone or more drops of blood may be extracted for testing. Some users,such as diabetics, for example, may have to test their blood sugarlevels several times a day. This may be accomplished by the user using asimple needle. However, this procedure is often problematic for the usersince the needle may be difficult to handle. Additionally, many userssimply cannot perform the procedure owing to either a fear of needles orbecause they lack a steady hand. As a result, lancet devices have beendeveloped which allow the user to more easily and reliably perform thisprocedure.

Most lancet devices lack convenient and flexible adjustability. Suchdevices are typically made adjustable by switching their tips. U.S. Pat.No. Re. 32,922 to LEVIN et al. is one such device. That is, the usermust remove one tip having a set depth and replace it with anotherhaving a different set depth. This, of course, creates the problem ofstoring the replaceable tips, which if not properly done, may result intheir misplacement, damage, contamination, or the like. Typical lancetdevices also require the user to handle the lancet during replacementand installation.

An improved device would allow the user to more easily adjust the depthof penetration and would overcome some of the disadvantages describedabove. Moreover, since the skin thickness can vary slightly from user touser and finger to finger, a need exists for efficiently adapting thedepth of penetration. For example, an index finger may be more callousedthan a middle finger, and the more calloused finger will typically havethicker skin. By adjusting the depth of puncture so that the depth is nogreater than necessary for extracting a required amount of blood, anypain experienced by the user may be minimized. The present device allowsthe user to more safely remove and replace a lancet after each use.

What is needed is a lancet device which can accurately and preciselycontrol the depth of penetration of the needle relative to the surfaceof the user's skin while also being easy to use. It is also desirablefor the user to be able to use and adjust the depth penetrating settingwith just one hand and/or with less effort that currently required withexisting lancet devices. What is also needed is a lancet device whichdoes not require the user to handle the lancets so as to preventinadvertent pricking of the user's skin.

SUMMARY OF THE INVENTION

According to one illustrative aspect of the invention there is provideda lancet device comprising a housing, a removable front cap mounted tothe housing, a lancet holding member, a trigger, a system for placingthe lancet device in a trigger-set or armed position, a depth adjustmentsystem comprising a member that is at least partially rotatably mountedand that has an axis of rotation arranged substantially perpendicular toa center axis of the lancet holding member, and an ejection system forat least one of preventing axial movement of the lancet holding memberand removing or ejecting a lancet from the lancet holding member.

The ejection system may comprise a manually activated slide button. Theejection system may each of prevent axial movement of the lancet holdingmember and remove or ejects the lancet from the lancet holding member.

The member that is at least partially rotatably mounted may comprise athumbwheel having plural cam or stop surfaces. The member that is atleast partially rotatably mounted may comprise a thumbwheel havingindicia. The member that is at least partially rotatably mounted maycomprise a thumbwheel having indicia which is visible through an openinglocated in the housing. The member that is at least partially rotatablymounted may comprise a thumbwheel having portions which can be grippedby a user from outside of the housing. The member that is at leastpartially rotatably mounted may comprise a thumbwheel having oppositelyarranged portions which project outside of the housing.

The lancet device may further comprise a first spring for causingmovement of the lancet holding member towards a puncturing position anda second for causing a back cap to move towards an initial position froma retracted position. The lancet device may further comprise a firstspring for causing movement of the lancet holding member towards apuncturing position, a second for causing a back cap to move towards aninitial position from a retracted position, and a third spring forcausing a slide member of the ejection system to move towards an initialposition from an extended position.

The invention also provides for a method of puncturing a surface of skinusing the lancet device of the type described above, wherein the methodcomprises arranging the lancet device adjacent against a user's skin andtriggering the lancet device so that a lancet is caused to penetrate theuser's skin.

The invention also provides for a lancet device comprising a housing, aremovable front cap mounted to the housing, a lancet holding memberhaving a front end adapted to receive therein a removable lancet, atrigger, a system for placing the lancet device in a trigger-set orarmed position, a depth adjustment system comprising a member havingplural cam surfaces, and an ejection system for at least one ofpreventing axial movement of the lancet holding member, removing orejecting a lancet from the lancet holding member, and removing orejecting the front cap.

The ejection system may comprise a manually activated slide button. Theejection system may each of prevent axial movement of the lancet holdingmember, remove or eject the lancet from the lancet holding member, andremove or eject the front cap.

The member may be at least partially rotatably mounted and comprises athumbwheel. The thumbwheel may comprise indicia. The indicia may bevisible through an opening located in the housing. The thumbwheel may beone of has portions which can be gripped by a user from outside of thehousing, and oppositely arranged portions which project outside of thehousing.

The lancet device may further comprise a first spring for causingmovement of the lancet holding member towards a puncturing position anda second for causing a back cap to move towards an initial position froma retracted position. The lancet device may further comprise a firstspring for causing movement of the lancet holding member towards apuncturing position, a second for causing a back cap to move towards aninitial position from a retracted position, and a third spring forcausing a slide member of the ejection system to move towards an initialposition from an extended position.

The invention also provides for a method of puncturing a surface of skinusing the lancet device of the type described above, wherein the methodcomprises arranging the lancet device adjacent against a user's skin andtriggering the lancet device so that a lancet is caused to penetrate theuser's skin.

The invention also provides for a lancet device comprising a housinghaving an ergonomic shape, a removable front cap mounted to the housing,a movably mounted lancet holding member having a front end adapted toreceive therein a removable lancet, a trigger arranged on a side wall ofthe hosing, a system for placing the lancet device in a trigger-set orarmed position, a depth adjustment system comprising a member havingplural cam surfaces, and an ejection system for at least one ofpreventing axial movement of the lancet holding member, removing orejecting a lancet from the lancet holding member, and removing orejecting the front cap.

The invention also provides for a lancet device of the type disclosedherein whose parts utilize the same materials as the materials ofcorresponding parts of U.S. Ser. No. 10/441,065 to SCHRAGA filed May 20,2003, the disclosure of this document is hereby expressly incorporatedby reference in its entirety.

Other exemplary embodiments and advantages of the present invention maybe ascertained by reviewing the present disclosure and the accompanyingdrawing.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is further described in the detailed descriptionwhich follows, in reference to the noted plurality of drawings by way ofnon-limiting examples of exemplary embodiments of the present invention,in which like reference numerals represent similar parts throughout theseveral views of the drawings, and wherein:

FIG. 1 shows a left front side perspective view of a non-limitingembodiment of the invention;

FIG. 2 shows a side cross-section view of FIG. 1. The device is shown inan initial or intermediate state;

FIG. 3 shows a side cross-section view of FIG. 2 after the device isplaced in an arming or trigger-set position;

FIG. 4 shows a side cross-section view of FIG. 2. The device is shown ina triggered state and before the lancet holding member is automaticallymoved back to the position shown in FIG. 2;

FIGS. 5 and 6 show an enlarged partial views of a front portion of thelancet device shown in FIG. 1 with the front cap being represented astransparent;

FIG. 7 shows a partial view of a front portion of the device of FIG. 1with the front cap removed and after the lancet ejection system has beenmoved to a lancet ejection position;

FIG. 8 shows a cross-section view of the front portion shown in FIG. 7after the lancet ejection system has been allowed to move to an initialposition;

FIG. 9 shows a cross-section view of the front portion shown in FIG. 7;

FIG. 10 shows a bottom partial view of a front portion (bottom housingpart removed) of the device of FIG. 1 with the front cap removed andafter the lancet ejection system has been moved to a lancet ejectionposition;

FIG. 11 shows a top partial view of a front portion (top housing partand lancet holding member removed) of the device of FIG. 1 with thefront cap removed and after the lancet ejection system has been moved toa lancet ejection position;

FIG. 12 shows a top partial view of a middle portion (top housing partand lancet holding member removed) of the device of FIG. 1 with thelancet ejection system in an initial position;

FIG. 13 shows an enlarged side cross-section view of a middle portion ofthe lancet device of FIG. 2 and illustrates the depth adjustment system;

FIG. 14 shows an enlarged side cross-section view of a middle portion ofthe lancet device of FIG. 4 and illustrates the depth adjustment system;

FIG. 15 shows a bottom side perspective view of the thumbwheel used inthe lancet device of FIGS. 13 and 14;

FIG. 16 shows an enlarged cross-section view of a rear portion of thelancet device of FIG. 3 and illustrates how the user can grip the backcap;

FIG. 17 shows the enlarged cross-section view of FIG. 16 and illustrateshow the user can move the back cap to a trigger-set position so as toplace the lancet device in the armed position of FIGS. 3 and 16;

FIGS. 18 and 19 show a front portion of the lancet device of FIG. 1 andshows how a user can see a visible indicator of when the lancet deviceis in an armed position;

FIG. 20 shows a perspective top side view of the upper or right-sidehousing part used in the two-piece housing of the lancet device shown inFIG. 1;

FIG. 21 shows a perspective outside view of the upper housing part shownin FIG. 20;

FIG. 22 shows a perspective inside view of the upper housing part shownin FIG. 21;

FIG. 23 shows a perspective bottom side view of the lower or left-sidehousing part used in the two-piece housing of the lancet device shown inFIG. 1;

FIG. 24 shows a perspective inside view of the lower housing part shownin FIG. 23;

FIG. 25 shows a perspective outside view of the lower housing part shownin FIG. 23;

FIG. 26 shows a perspective inside view of the front cap used in thelancet device shown in FIG. 1;

FIG. 27 shows a perspective outside view of the front cap shown in FIG.26;

FIG. 28 shows a perspective rear side view of an upper portion of theback cap used in the lancet device shown in FIG. 1;

FIG. 29 shows an enlarged perspective rear side view of an upper portionof the back cap used in the lancet device shown in FIG. 1;

FIG. 30 shows a perspective inside view of the upper portion of the backcap shown in FIG. 29;

FIG. 31 shows a perspective rear side view of a lower portion of theback cap used in the lancet device shown in FIG. 1;

FIG. 32 shows an enlarged perspective rear side view of a lower portionof the back cap used in the lancet device shown in FIG. 1;

FIG. 33 shows a perspective inside view of the lower portion of the backcap shown in FIG. 32;

FIG. 34 shows a perspective front side view of the thumb wheel used inthe embodiment of FIG. 1;

FIG. 35 shows an enlarged view of FIG. 34;

FIG. 36 shows a perspective rear side view of the thumb wheel shown inFIG. 35;

FIG. 37 shows a perspective front side view of the trigger used in theembodiment of FIG. 1;

FIG. 38 shows an enlarged view of FIG. 37;

FIG. 39 shows a perspective rear side view of the trigger shown in FIG.38;

FIG. 40 shows a bottom side perspective view of the lancet ejectionmember used in the lancet device shown in FIG. 1;

FIG. 41 shows a top side perspective view of the lancet ejection membershown in FIG. 40;

FIG. 42 shows a top perspective view of the lancet holding member usedin the lancet device shown in FIG. 1;

FIG. 43 shows a top left-side perspective view of FIG. 42;

FIG. 44 shows a bottom right-side perspective rear side view of FIG. 43;

FIG. 45 shows a perspective side view of the lancet holding member/backcap return spring used on the lancet device of FIG. 1;

FIG. 46 shows a perspective side view of the drive spring which causesthe lancet holding member to move to the puncturing position of thelancet device shown in FIG. 1;

FIG. 47 shows a perspective side view of the spring used to bias thelancet ejection system of the lancet device shown in FIG. 1;

FIG. 48 shows a top perspective view of the locking member used in thelancet device shown in FIG. 1; and

FIG. 49 shows a bottom perspective view of the locking member shown inFIG. 48.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

The particulars shown herein are by way of example and for purposes ofillustrative discussion of the embodiments of the present invention onlyand are presented in the cause of providing what is believed to be themost useful and readily understood description of the principles andconceptual aspects of the present invention. In this regard, no attemptis made to show structural details of the present invention in moredetail than is necessary for the fundamental understanding of thepresent invention, the description taken with the drawings makingapparent to those skilled in the art how the several forms of thepresent invention may be embodied in practice.

FIGS. 1-49 show one non-limiting embodiment of a lancet device LD. Thelancet device LD includes the following main components: a housing orbody 10 which preferably comprises housing parts 10A and 10B, a frontcap 20, a back cap 30 which preferably comprises parts 30A and 30B, atrigger 40, a lancet advance button or member 50, a locking member 60, alancet holding member 70, a depth adjustment or thumb wheel member 80,and three springs S1, S2 and S3.

As can be seen in FIG. 1, the lancet device LD can preferably have, byway of non-limiting example, an overall length OL which is approximately5 inches and an overall width or diameter (measured over the device'slargest portion) of approximately 1.25 inches. The lancet device LD alsopreferably has an ergonomic shape such that it can be held comfortablyin a user's hand such that the user can rotate (both clockwise andcounterclockwise) the depth adjustment thumb wheel 80 with the user'sthumb and index finger, as will be described in detail later on, to setthe depth of penetration prior to use. The user can also depress andslide forward the advance button 50 in order cause a forward advance ofa lancet and optionally simultaneously cause removal of the front cap20, as will be described in detail later on. The user can also depressthe trigger 40 with either the user's thumb of index finger. The onlystep which likely requires the user to use two hands, is the step ofplacing the lancet device LD is an armed or trigger-set position—whichwill be described in detail later on.

As can be seen in FIGS. 2-4, the lancet device LD functions as follows:In the position shown in FIG. 2, the lancet device LD is shown in thestatic or initial position. This is the preferred position that thedevice would assume during shipping, storage, and after the device istriggered or fired. In this position, the drive spring S1 is in arelaxed or non-compressed or expanded position. The back or armingspring S2 is in a slightly compressed state so as to apply a biasingforce that forces the back cap 30 to a forward-most position. Theadvance button 50 and the trigger 40 are also in an initial position.The slide spring S3 (not visible in FIG. 2) is in a slightly compressedstate so as to apply a biasing force that forces the ejection slidemember 50 to a rearward-most position.

In the position shown in FIG. 3, the lancet device LD is shown in theloading, armed or trigger-set position. This is the position which armsthe lancet device and occurs when the user moves the back cap 30rearward to cause the deflecting member 72 to become releasably lockedto the retaining shoulder RS. In this position, the spring S1 is in acompressed state or position. Spring S2 is in an almost relaxed or amore expanded state or position, but is still able to bias the back cap30 toward an initial position. The arming or armed position shown inFIG. 3 can take place when the user grips the back cap 30 with one handand the body 10 with the other hand and pulls the back cap 30 away fromthe body 10, and then lets go of the back cap 30.

In the position shown in FIG. 4, the lancet device LD is shown in thefiring or fired position. This is the position in which a user depressesthe trigger 40 so as to cause the member 72 to deflect inwardly andrelease from the shoulder RS. This releases the energy stored in thespring S1 and causes the lancet holding member 70 to move forwardly,which automatically causes the lancet L to project out of the frontsurface of the front cap 20 and cause a puncture in a user's skin. Ofcourse, the position shown in FIG. 4 merely shows a snap-shot of thelancet needle LN in the extended or puncturing position, i.e., definedby the puncturing depth PD. In actuality, the lancet needle LN wouldmove from the position in FIG. 3 (fully retracted or trigger-setposition) to that of FIG. 4 (fully extended or puncturing position), andthen finally to that of FIG. 2 (initial position) in a fraction of asecond. In the firing position, the spring S1 is in a substantiallyfully expanded position owing to the forward movement of the member 70as caused by the rapid axial expansion of the spring S1 acting on theflange of surface 77 c of member 70. After the member 70 moves to amaximum forward position shown in FIG. 4, as determined by contactbetween a free end of the lancet L and an inner surface of the front cap20 and/or by contact between the projection 78 and projection 10B27, thespring S2, which has substantially reached a maximum amount of allowablecompression, will expand axially back to an original position, which, inturn, places the lancet device LD back in the position shown in FIG. 2.At this point, the user has the option of activating the lancetadvancing system LES (see FIGS. 7-9) in order to cause removal of thefront cap 20 and to allow for removal of the used lancet L so that thenext or a fresh lancet can be placed on the lancet holding member 70.

With reference to FIGS. 5 and 6, it can be seen that the lancet deviceLD includes a removable front cap 20 which covers a front area of thelancet device LD that includes a front end of the lancet holding member70 and a lancet L. The lancet L is axially retained inside an elongatedcylindrical opening LRO (see FIG. 44) of the lancet holding member 70 bydeflectable portions of the front end portion 71 a which engages with anouter cylindrical surface of the lancet L. Thus, when the lancet holdingmember 70 moves axially within housing 10, the lancet L moves alongtherewith. As is apparent from FIGS. 5 and 6, the front cap 20 can beremovably secured to the housing 10 via engagement between oppositelyarranged projections 27 and grooves G formed in housing parts 10A and10B. Other types of connections can be utilized such as a snapconnection of the type disclosed in U.S. Pat. Nos. 5,908,434 to SCHRAGAand 6,530,937 to SCHRAGA. The disclosure of each of these documents ishereby expressly incorporated by reference in its entirety. In order toremove the front cap 20, the user can either rotate the front cap 20relative to the housing 10 (by e.g., about 90 degrees) to cause theprojections 27 to align with oppositely arranged axial slots AL and thensimply pull the front cap 20 away from the housing 10 or the user canmove the slide member 50 forward (see FIGS. 7 and 9) to cause the end 53to move into engagement with end 21 of the front cap 20 and therebycause the projections 27 to come out of snap engagement with the groovesG.

The details of the lancet ejecting system LES will now be described withreference to FIGS. 7-12. FIG. 8 shows the system LES in an initialposition. In this position, the slide member 50 has a button portion 51abutting or substantially near surfaces 10A14 and 10B14 (see FIGS. 22and 24). FIGS. 7 and 9 show the system LES in a final or activatedposition. In this position, the slide member 50 has a button portion 51abutting or substantially near surfaces 10A15 and 10B15 (see FIGS. 22and 24). A spring S3 is arranged in a retaining groove 10B26 and appliesa biasing force against surface 10B20 a and a surface of member 54 (seeFIG. 12). In operation, the advance button 50 is slid forward from theposition shown in FIG. 8 to the position shown in FIGS. 7 and 9. Thiscauses compression of the spring S3 and causes the lancet engagingmember 55 (which extends into the holding member 70 via the elongatedslot 79) to engage or contact a rear end of lancet L. However, when theslide member 50 is slid forward slightly against the biasing force ofspring S3, this initial forward movement of the slide member 50automatically causes the locking member 60 to pivot about axleprojection 10B10 so that projection 65 engages with shoulder 78 (seeFIG. 10) of the lancet holding member 70. This pivoting movement of thelocking member 60 occurs as a result of sliding interaction between theguide projection 64 and the guide groove 57. Continued forward slidingmovement of the slide member 50 causes the lancet L to move or advanceforwards (until finally ejected) while the lancet holding member 70 isaxially retained by the locking member 60. This forward movement of theslide member 50 maintains the locking member 60 in the locking positionbecause of continued engagement between the guide projection 64 and theguide slot 57. Although not shown in FIGS. 7-12, the end 53 also moveswith button 51 and would cause the front cap 20 to be removed along withthe lancet L. This causes the front cap 20 to be ejected and allows theuser to install a fresh or new lancet L. The user can then release theadvance button 50 (which will be automatically retracted by the springS3) and re-install the front cap 20 in order to place the device LD backinto an initial or intermediate position shown in FIG. 2.

With reference to FIGS. 13-15 it can be seen that the user can set adepth of penetration of the lancet device LD before the device istriggered and/or after the device is triggered. This can occur by theuser rotating the thumb wheel 80 in either clockwise or counterclockwisedirections. Such rotational movement determines the maximum forwardposition of the lancet holding member 70 and specifically projection 74.This position of the projection 74 (which contacts one of the stopsurfaces 86 a-86 f) also determines the amount of forward axial movementof the lancet holding member 70 as discussed above. This movementchanges as a result of the rotational position of the surfaces 86 a-86 fof the thumb wheel 80 relative to the projection 74, such that when stopsurface 86 a of the thumb wheel 80 is contacted by projection 74, theholding member 70 moves axially forward by a greater amount (producing adeeper puncture) than when stop surface 86 f of the thumb wheel 80 iscontacted by projection 74 producing a shallower puncture). The user candistinguish which stop surface 86 a-86 f is located in a position to becontacted by projection 74 by viewing the corresponding indicia 88 (seeFIGS. 34-36) through the window or opening 10A13 in the housing 10 (seeFIG. 14).

FIGS. 16 and 17 show how the lancet device LD can be armed or placed inthe trigger-set position of FIG. 3. This is the position which arms thelancet device and occurs when the user moves the back cap 30 rearward tocause the deflecting member 72 to become releasably locked to theretaining shoulder RS (see FIG. 3). During this movement, the spring S2is compressed. However, when the user releases his or her grip from theback cap 30, the spring S2 automatically causes the back cap 30 to movetoward an initial position shown in FIG. 16. The user can grip theindentations 30A4 and 30B4 of the back cap 30 with one hand and the body10 with the other hand and pull the back cap 30 away from the body 10,and then let go of the back cap 30.

FIGS. 18 and 19 show how the lancet device LD can provide a indicationto the user that the device is armed or placed in the trigger-setposition of FIG. 3, thereby providing a safety feature. By way ofnon-limiting example, the trigger 40 includes an opening or transparentwindow 46 (see FIG. 38) which allows a user to see inside the device. Assuch, when the lancet holding member 70 is positioned in the positionshown in FIG. 3, the indicator 73 (in the form of, e.g., a red dot) canbe visible through the window 46 (see FIG. 43), thereby providing avisual indicator to the user of the armed position. Of course, when thelancet holding member 70 is in the position shown in FIG. 2, theindicator 73 (in the form of, e.g., a red dot) is not visible throughthe window 46, thereby providing a visual indicator to the user of theunarmed position.

The details of the parts utilized in the lancet device LD shown in FIGS.1-4 will now be described with reference to FIGS. 20-49.

With reference to FIGS. 20-22, it can be seen that the upper housingpart 10A includes a front end 10A1 having a partially cylindrical innersurface 10A4 and a partially cylindrical outer surface 10A3 which servesas a mounting area for the front cap 20 as well as a rear end 10A2. Agenerally helical groove G is arranged on the surface 10A3 of thehousing part 10A and is configured to receive therein one of theprojections 27 of the front cap 20. The semi-cylindrical portion 10A3which (together with semi-cylindrical portion 10B3) is sized andconfigured to slidably and rotatably receive thereon the rear end of thefront cap 20. The housing part 10A also has a main body portion 10A5which is preferably ergonomically shaped. Oppositely arranged integrallyformed projections 10A6 each extend or projects inwardly from the bodyportion 10A5 and includes a mounting opening which is sized andconfigured to receive therein one of the mounting projections 10B6.Oppositely arranged integrally formed projections 10A7 each extend orprojects inwardly from the body portion 10A5 and includes a mountingopening which is sized and configured to receive therein one of themounting projections 10B7. Oppositely arranged integrally formedprojections 10A8 each extend or projects inwardly from the body portion10A5 and includes a mounting opening which is sized and configured toreceive therein one of the mounting projections 10B8. A centrallyarranged mounting projection 10A9 extends inwardly from the body portion10A5 and is sized to allow the thumbwheel 80 to be rotatably mountedthereto. Projections 10A24 are configured to function as a bearingsurface for the surface 81 of the thumbwheel 80. A trigger opening 10A10is formed in the body portion 10A5 and is sized and configured toreceive therein the projecting portions 43 a and 43 b of the trigger 40(see FIGS. 37-39). Once inserted in the opening 10A10, the projectingportions 43 a and 43 b of the trigger 40 prevent removal of the trigger40 from the housing part 10A, but allow the trigger 40 to move againstthe biasing force of an integrally formed deflecting member 10A11 whichfunctions as a flat spring and bias the trigger 40 towards an extendedor initial position. The deflectable member 10A11 is deflected bycontact with projection 44 of the trigger 40 when the trigger 40 isdepressed. A retaining shoulder RS is formed in the body portion 10A5and is configured to releasably engage and/or lock with a deflectingportion 72 of the lancet holding member 70 (see FIGS. 42-44). Oppositelyarranged indented sections 10A12 are arranged in an area of the middlerear end of the housing part 10A and together with indented section10B12 form an area for the user to activate the thumbwheel 80. A viewingopening 10A13 is arranged in the body portion 10A5 of the front end ofthe housing part 10A, which allows a user to view indicia 88 of thethumbwheel 80 when the thumbwheel 80 is mounted to the projection 10A9.A half-slot or half-groove defined by surfaces 10A14 and 10A15 (togetherwith half-groove formed by surfaces 10B14 and 10B15) forms a guidegroove which guides the sliding movement of the slide member 50 betweenan initial and final position (see FIGS. 8 and 9). The slide member 50contacts and/or substantially abuts stop surface 10A14 in the initialposition shown in FIG. 8 (as a result of the biasing force of the springS3) and contacts and/or substantially abuts stop surface 10A15 in thefinal position shown in FIG. 9 (as a result of the user causingcompression of the spring S3). Oppositely arranged reinforcing ribs10A16 are also utilized. A projection 10A17 is utilized to abutprojection 10B14 and prevent axial movement of the ring portion 61 ofthe locking member 60. A rear portion of the housing part 10A includessurface 10A19 which is configured to abut with surface 10B19 of thehousing part 10B, and a groove 10A22 which slidably receives thereinprojection 30A6. Housing part 10A also includes reinforcing projections10A20 and 10A21. The rear portion of the housing part 10A also includessurface 10A23 which is configured to be slidably engaged by the innersurface of portion 30A1 as well as oppositely arranged guide surfaces10A25 which are sized and configured to be slidably engaged by the innersurfaces of members 30A3. The guide surfaces 10A25 extend into openingsin the member 10A so as to form slots 10A25 a (see FIG. 22). As isapparent from FIGS. 20-22, the housing part 10A can preferably be aone-piece member and is most preferably a one-piece synthetic resinmember. Of course, the member 10A can also be an assembly of pluralcomponents provided it functions in a manner similar to that of themember shown in FIGS. 20-22.

With reference to FIGS. 23-25, it can be seen that the lower housingpart 10B includes a front end 10B1 having a partially cylindrical innersurface 10B4 and a partially cylindrical outer surface 10B3 which servesas a mounting area for the front cap 20 as well as a rear end 10B2. Agenerally helical groove G is arranged on the surface 10B3 of thehousing part 10B and is configured to receive therein one of theprojections 27 of the front cap 20. The semi-cylindrical portion 10B3which (together with semi-cylindrical portion 10A3) is sized andconfigured to slidably and rotatably receive thereon the rear end of thefront cap 20. The housing part 10B also has a main body portion 10B5which is preferably ergonomically shaped. Oppositely arranged integrallyformed projections 10B6 each extend or projects inwardly from the bodyportion 10B5 and is sized and configured to extend into the opening ofmounting projections 10A6. Oppositely arranged integrally formedprojections 10B7 each extend or projects inwardly from the body portion10B5 and is sized and configured to extend into the openings in themounting projections 10A7. Oppositely arranged integrally formedprojections 10B8 each extend or projects inwardly from the body portion10B5 and are sized and configured to extend into the mounting openingsof the mounting projections 10A8. A centrally arranged D-shaped guideprojection 10B9 extends inwardly from the body portion 10B5 and has anupper surface 10B24 configured to abut surface 87 of the thumbwheel 80.The projection 10B9 also extends through the slot 77 b and into thespace 77 a of the holding member 70, and participates in guiding theaxial movement of the holding member 70. A guide surface arrangement10B11 is formed in the body portion 10B5 and is configured to supportand allow for the sliding and/or pivoting movement of the locking member60 (see FIG. 11). Oppositely arranged indented sections 10B12 arearranged in an area of the middle rear end of the housing part 10B andtogether with indented section 10A12 form an area for the user toactivate the thumbwheel 80. Oppositely arranged support surfaces 10B13are arranged on the body portion 10B5 and are configured to be slidablyengaged by the surface 82 of the thumbwheel 80. A half-slot orhalf-groove defined by surfaces 10B14 and 10B15 (together withhalf-groove formed by surfaces 10A14 and 10A15) forms a guide groovewhich guides the sliding movement of the slide member 50 between aninitial and final position (see FIGS. 8 and 9). The slide member 50contacts and/or substantially abuts stop surface 10B14 in the initialposition shown in FIG. 8 (as a result of the biasing force of the springS3) and contacts and/or substantially abuts stop surface 10B15 in thefinal position shown in FIG. 9 (as a result of the user causingcompression of the spring S3). Oppositely arranged reinforcing ribs10B16 are also utilized. A projection 10B17 is utilized to support andguide the movement of a middle rear portion of the holding member 70(see FIGS. 2 and 4). A rear portion of the housing part 10B includessurface 10B19 which is configured to abut with surface 10A19 of thehousing part 10A, and a groove 10B22 which slidably receives thereinprojection 30B6. Housing part 10B also includes reinforcing projections10B18, 10B20 and 10B21, and each of these projections utilize asemi-circular recess which slidably supports the lancet holding member70. The rear portion of the housing part 10B also includes surface 10B23which is configured to be slidably engaged by the inner surface ofportion 30B1 as well as oppositely arranged guide surfaces 10B25 whichare sized and configured to be slidably engaged by the inner surfaces ofmembers 30B3. The guide surfaces 10B25 extend into openings in themember 10B so as to form slots 10B25 a (see FIG. 24). An elongatedrecess or groove 10B26 is formed in the member 10B5 and is sized toreceive therein the spring S3 and be slidably engaged by the projection54 (see FIG. 12). A projection 10B27 is utilized to support and guidethe movement of a front portion of the holding member 70. As is apparentfrom FIGS. 23-25, the housing part 10B can preferably be a one-piecemember and is most preferably a one-piece synthetic resin member. Ofcourse, the member 10B can also be an assembly of plural componentsprovided it functions in a manner similar to that of the member shown inFIGS. 23-25.

With reference to FIGS. 26 and 27, it can be seen that the front cap 20includes a skin contacting surface 25 which includes a lancet needleopening 24 sized and located to allow one of the lancet needles LN topass or extend there through. The front cap 20 has an outer taperedgenerally circular surface 22, a rear end 21, and a generally planarfront surface 23 The front cap 20 preferably include mechanisms, i.e.,oppositely arranged projections 27, arranged on inner generallycylindrical surface 26 to ensure that the front cap 20 is removablymounted to the grooves G of the front end of the housing 10. A shoulder28 is structured and arranged to be contacted by the end 53 of the slidemember 50 (so as to allow the slide member 50 to pop-off the front cap20), and to abut the ends 10A1 and 10B1 of the housing parts 10A and10B. As is apparent from FIGS. 26 and 27, the front cap 20 canpreferably be a one-piece member and is most preferably a one-piecesynthetic resin member. Of course, the front cap 20 can also be anassembly of plural components provided it functions in a manner similarto that of the member shown in FIGS. 29 and 30.

With reference to FIGS. 28-33, it can be seen that the back cap 30includes two main parts, i.e., upper back cap portion 30A and lower backcap portion 30B. The upper portion 30A includes a front end 30A1, agripping indentation 30A4, a tapered and rounded portion 30A7, a rearend 30A2. The two projections 30A3 serve to guide the linear movement ofthe back cap 30 relative to the housing 10 by slidably engaging with thesurfaces 10A25. A centrally arranged projection 30A6 extends into thegroove 10A22 and has an opening which receives therein the projection30B8 of the back cap part 30B. A bottom surface 30A5 is configured toabut the surface 30B5 of the part 30B and has openings which receivetherein the projection 30B9 of the back cap part 30B. The lower portion30B includes a front end 30B1, a gripping indentation 30B4, a taperedand rounded portion 30B7, a rear end 30B2. The two projections 30B3serve to guide the linear movement of the back cap 30 relative to thehousing 10 by slidably engaging with the surfaces 10B25. A centrallyarranged projection 30B6 extends into the groove 10B22 and has aprojection which extend into an opening in the projection 30A6 of theback cap part 30A. A bottom surface 30B5 is configured to abut thesurface 30A5 of the part 30A and has projections which extend into theopenings in surface 30A5. The rear facing surface of the projection 30B6is configured to be contacted by a front end of the spring S2. Thisallows the spring S2 to bias the back cap 30 towards the position shownin FIG. 16 and automatically moves the back cap 30 back to the positionshown in FIG. 16 when the user releases the back cap 30 from theposition shown in FIG. 17. As is apparent from FIGS. 28-33, the back cap30 can preferably be a two-piece member and is most preferably atwo-piece synthetic resin member. Of course, the back cap 30 can also bea one-piece member and/or an assembly of more than two componentsprovided it functions in a manner similar to that of the member shown inFIGS. 28-33.

With reference to FIGS. 34-36, it can be seen that the depth adjustmentmember or thumb wheel 80 includes an upper bearing surface 81 which isconfigured to slidably engage with the projections 10A24, a rear surface82 which is configured to slidably engage with the surfaces 10B13, and arear surface 87 which is configured to slidably engage with the surface10B24. In this way, the thumb wheel 80 is axially retained within thehousing 10. A generally cylindrical projection 83 is sized to rotatablyengaged with and mount to an opening formed in the projection 10A9. Thethumb wheel 80 also includes an outer surface 84 adapted to befrictionally engaged by a user's fingers which allow a user to easilygrip the thumb wheel 80 and rotate it relative to the housing 10 in eachof a clockwise and counterclockwise directions. Any type of frictionsurface can also be utilized in the area 84. The thumb wheel 80 alsoincludes a main projection 85. The main projection 85 includes a numberor cam or stop surfaces 86 a-86 f which function to control the depth ofpenetration of the lancet needle LN and/or which control the distance PD(see FIG. 4). The depth of penetration PD is adjusted or predeterminedby the rotational position of the thumb wheel 80 relative to the housing10 and more specifically by the rotational position of the surfaces 86a-86 f relative to the movably stop surface 74. Maximum depth ofpenetration PD results when the projection 74 contacts stop surfaces 86a whereas minimum depth of penetration PD results when the projection 74contacts stop surface 86 f. The thumb wheel 80 also utilizes indicia 88which functions to provide the lancet device LD with a system forindicating to the user the position of depth adjustment, i.e., therotational position of the thumb wheel 80, so that the user candetermine whether to change the depth of penetration. An indicator,e.g., window 10A13, is arranged on the housing 10 and allows the user tosee the indicia 88. By way of non-limiting example, the indicia value“1” (viewed in the window 10A13) can correspond to the stop surface 86 fbeing located in a position allowing it to be contacted by theprojection 74; the indicia value “2” (viewed in the window 10A13) cancorrespond to the stop surface 86 e being located in a position allowingit to be contacted by the projection 74; the indicia value “3” (viewedin the window 10A13) can correspond to the stop surface 86 d beinglocated in a position allowing it to be contacted by the projection 74;the indicia value “4” (viewed in the window 10A13) can correspond to thestop surface 86 c being located in a position allowing it to becontacted by the projection 74; the indicia value “5” (viewed in thewindow 10A13) can correspond to the stop surface 86 b being located in aposition allowing it to be contacted by the projection 74; and theindicia value “6” (viewed in the window 10A13) can correspond to thestop surface 86 a being located in a position allowing it to becontacted by the projection 74. As is apparent from FIGS. 34-36, thethumb wheel 80 can preferably be a one-piece member and is mostpreferably a one-piece synthetic resin member. Of course, the thumbwheel 80 can also be an assembly of plural components provided itfunctions in a manner similar to that of the member shown in FIGS.34-36.

With reference to FIGS. 37-39, it can be seen that the trigger 40includes a generally circular upper surface 41 which is configured to becontacted by a user finger. The trigger 40 also includes two oppositelyarranged projections 43 a and 43 b which are configured to snap into theopening 10A10 and prevent removal of the trigger 40 once installed onthe body portion 10A. A generally circular projection 45 is configuredto contact free end portion of the deflectable member 10A11. Theprojection 45 has a opening 47 which is aligned with a window 46 andtogether allows the user to view the red indicator 73 when the lancetdevice LD is in the trigger-set position. A generally rectangularprojection 44 is configured to contact the deflectable member 72 andcause the shoulder of the deflectable member 72 (see FIG. 43) todisengage from the retaining shoulder RS after the lancet device LD isin a trigger-set position (see e.g., FIG. 3) and the trigger 40 isdepressed. As is apparent from FIGS. 37-39, the trigger 40 canpreferably be a one-piece member and is most preferably a one-piecesynthetic resin member. Of course, the trigger 40 can also be anassembly of plural components provided it functions in a manner similarto that of the member shown in FIGS. 37-39.

With reference to FIGS. 40 and 41, it can be seen that the slide oradvance member 50 includes a generally circular button portion 51 whichis configured to be contacted by a user finger. A front free end 52 isarranged on one end of a main portion 52 and is configured to contactthe shoulder 28 of the front cap 20. A rear projection 54 is arranged onanother end of a main portion 52 and is configured to contact a rear endof the spring S3 (see FIG. 12). A generally rectangular projection 55 isconfigured to extend into and slide within the slot 79 of member 70. Themember 55 has a front edge 58 that is configured to engage or contact arear surface of the lancet L and has two oppositely arranged planarsurfaces. A through slot 57 is formed on member 56 and is configured toslidably engage with cam projection 64 of locking member 60. As isapparent from FIGS. 40 and 41, the advance button 50 can preferably be aone-piece member and is most preferably a one-piece synthetic resinmember. Of course, the member 50 can also be an assembly of pluralcomponents provided it functions in a manner similar to that of themember shown in FIGS. 40 and 41.

With reference to FIGS. 42-44, it can be seen that the lancet holdingmember 70 includes an annular front end 71 a having a generallycylindrical opening LRO sized to receive therein a lancet L, and a rearend 71 b which includes a shoulder 75 configured to retain therein arear end of the spring S2. The member 70 has a generally cylindricalbody portion 71 c sized to slidably engaged with support and guidesurfaces of the housing parts 10A5 and 10B5. The member 70 also includesa deflectable projection 72 which is configured to releasably lock toretaining shoulder RS. A color, e.g., red, indicator dot 73 is providedto indicate to the user when the holding member 70 is located in atrigger-set position. The member 70 also includes a stop projection 74which is configured to contact one of the plurality of stop surfaces 86a-86 f. A semi-cylindrical area 77 a is sized to receive therein thespring S1 whereas semi-cylindrical area 76 a is sized to receive thereinthe spring S2. The elongated slot 77 b is sized to receive therein 10B9and the elongated slot 76 b is sized to receive therein 30B6. Thesurface 77 c is configured to be contacted by a front end of the springS1. An elongated slot 79 is sized to slidably receive therein the lancetejecting portion 55 of the slide member 50. The member 70 also includesa stop projection 78 which is configured to contact and slidably engageguide surface 10B28, and can optionally engage with the stop projection10B27. As is apparent from FIGS. 42-44, the member 70 can preferably bea one-piece member and is most preferably a one-piece synthetic resinmember. Of course, the member 70 can also be an assembly of pluralcomponents provided it functions in a manner similar to that of themember shown in FIGS. 42-44.

With reference to FIGS. 45-47, it can be seen that the main spring S1,the return spring S2 and the slide member return spring S3 can have theform of helical wire compression springs. Each spring S1-S3 ispreferably be a one-piece member and is most preferably a one-piecespring metal member. Of course, the springs can also be made of anymaterial provided they function in a manner similar to that of themembers shown in FIGS. 45-47.

With reference to FIGS. 48 and 49, it can be seen that the lockingmember 60 includes a rear end 61 having an opening 62 which receivestherein projection 10B10 and a forward end 63. An upstanding elongatedprojection 64 is configured to slidably engage with recess 57 of theslide 50. Such engagement causes pivoting movement of the end 63 aboutopening 62 between a position wherein the projection 65 locks withprojection 78 (see FIG. 10) and an initial position wherein theprojection 65 does not contact projection 78. An opposite facing surfaceto surface 63 is configured to slidably engage with a generally planarsurface 10B11 (see FIG. 11). As is apparent from FIGS. 48 and 49, thelocking member 60 can preferably be a one-piece member and is mostpreferably a one-piece synthetic resin member. Of course, the member 60can also be an assembly of plural components provided it functions in amanner similar to that of the member shown in FIGS. 48 and 49.

One or more of the parts of the lancet device LD such as, e.g., thehousing 10 and front cap 20 can preferably made transparent and/ortranslucent so that a user will clearly be able to see internalcomponents. The device can also utilize one or more features ormodifications disclosed in U.S. 2006/0173478 to SCHRAGA, the disclosureof which is hereby expressly incorporated by reference in its entirety.

All the parts of the lancet device LD, with the exception of the springsand needles (which can respectively be made of spring steel andstainless steel), may be made from plastic materials and can be formedusing conventional injection molding techniques or other knownmanufacturing methods. Bay way of non-limiting example, all or most ofthe parts such as the housing, trigger, front and back caps, thumbwheel, advance button, slide plate, lancet engaging member, lockingmember can be made of ABS plastic with the exception of the springs(which can be stainless steel) and the lancet holding member which canbe made of polyoxymethylene (Delrin plastic). However, when practical,other materials and manufacturing processes may also be utilized.

It is noted that the foregoing examples have been provided merely forthe purpose of explanation and are in no way to be construed as limitingof the present invention. While the present invention has been describedwith reference to an exemplary embodiment, it is understood that thewords which have been used herein are words of description andillustration, rather than words of limitation. Changes may be made,within the purview of the appended claims, as presently stated and asamended, without departing from the scope and spirit of the presentinvention in its aspects. Although the present invention has beendescribed herein with reference to particular means, materials andembodiments, the present invention is not intended to be limited to theparticulars disclosed herein; rather, the present invention extends toall functionally equivalent structures, methods and uses, such as arewithin the scope of the appended claims.

1. A lancet device comprising: a housing; a removable front cap mountedto the housing; a lancet holding member; a trigger; a system for placingthe lancet device in a trigger-set or armed position; a depth adjustmentsystem comprising a member that is at least partially rotatably mountedand that has an axis of rotation arranged substantially perpendicular toa center axis of the lancet holding member; and an ejection system forat least one of: preventing axial movement of the lancet holding member;and removing or ejecting a lancet from the lancet holding member.
 2. Thelancet device of claim 1, wherein the ejection system comprises amanually activated slide button.
 3. The lancet device of claim 1,wherein the ejection system each of prevents axial movement of thelancet holding member and removes or ejects the lancet from the lancetholding member.
 4. The lancet device of claim 1, wherein the member thatis at least partially rotatably mounted comprises a thumbwheel havingplural cam or stop surfaces.
 5. The lancet device of claim 1, whereinthe member that is at least partially rotatably mounted comprises athumbwheel having indicia.
 6. The lancet device of claim 1, wherein themember that is at least partially rotatably mounted comprises athumbwheel having indicia which is visible through an opening located inthe housing.
 7. The lancet device of claim 1, wherein the member that isat least partially rotatably mounted comprises a thumbwheel havingportions which can be gripped by a user from outside of the housing. 8.The lancet device of claim 1, wherein the member that is at leastpartially rotatably mounted comprises a thumbwheel having oppositelyarranged portions which project outside of the housing.
 9. The lancetdevice of claim 1, further comprising a first spring for causingmovement of the lancet holding member towards a puncturing position anda second for causing a back cap to move towards an initial position froma retracted position.
 10. The lancet device of claim 1, furthercomprising a first spring for causing movement of the lancet holdingmember towards a puncturing position, a second for causing a back cap tomove towards an initial position from a retracted position, and a thirdspring for causing a slide member of the ejection system to move towardsan initial position from an extended position.
 11. A method ofpuncturing a surface of skin using the lancet device of claim 1, themethod comprising: arranging the lancet device adjacent against a user'sskin; and triggering the lancet device so that a lancet is caused topenetrate the user's skin.
 12. A lancet device comprising: a housing; aremovable front cap mounted to the housing; a lancet holding memberhaving a front end adapted to receive therein a removable lancet; atrigger; a system for placing the lancet device in a trigger-set orarmed position; a depth adjustment system comprising a member havingplural cam surfaces; and an ejection system for at least one of:preventing axial movement of the lancet holding member; removing orejecting a lancet from the lancet holding member; and removing orejecting the front cap.
 13. The lancet device of claim 12, wherein theejection system comprises a manually activated slide button.
 14. Thelancet device of claim 12, wherein the ejection system each of preventsaxial movement of the lancet holding member, removes or ejects thelancet from the lancet holding member, and removes or ejects the frontcap.
 15. The lancet device of claim 12, wherein the member is at leastpartially rotatably mounted and comprises a thumbwheel.
 16. The lancetdevice of claim 15, wherein the thumbwheel comprises indicia.
 17. Thelancet device of claim 16, wherein the indicia is visible through anopening located in the housing.
 18. The lancet device of claim 15,wherein the thumbwheel one of has portions which can be gripped by auser from outside of the housing, and oppositely arranged portions whichproject outside of the housing.
 19. The lancet device of claim 12,further comprising a first spring for causing movement of the lancetholding member towards a puncturing position and a second for causing aback cap to move towards an initial position from a retracted position.20. The lancet device of claim 12, further comprising a first spring forcausing movement of the lancet holding member towards a puncturingposition, a second for causing a back cap to move towards an initialposition from a retracted position, and a third spring for causing aslide member of the ejection system to move towards an initial positionfrom an extended position.
 21. A method of puncturing a surface of skinusing the lancet device of claim 12, the method comprising: arrangingthe lancet device adjacent against a user's skin; and triggering thelancet device so that a lancet is caused to penetrate the user's skin.22. A lancet device comprising: a housing having an ergonomic shape; aremovable front cap mounted to the housing; a movably mounted lancetholding member having a front end adapted to receive therein a removablelancet; a trigger arranged on a side wall of the hosing; a system forplacing the lancet device in a trigger-set or armed position; a depthadjustment system comprising a member having plural cam surfaces; alocking member configured to prevent axial movement of the lancetholding member; and an ejection system configured to remove or eject alancet from the lancet holding member.